For middle-aged and elderly patients with conditions such as spinal fractures and degenerative spinal diseases, spinal internal fixation is a core surgical procedure for reconstructing spinal stability, heavily relying on the biomechanical stability provided by pedicle screw systems. Whereas, these patients are often complicated by osteoporosis that can significantly compromise the stability of the bone-pedicle screw interface, leading to a marked increase in pedicle screw loosening and surgical failure rates. The bone cement-augmented pedicle screw technique, which involves injecting bone cement into the vertebral body or screw trajectory to optimize the mechanical properties of the bone-pedicle screw composite, has been proven to significantly enhance fixation strength and effectively prevent screw-related failures, thereby reducing the incidence of internal fixation failure in high-risk populations undergoing spinal fusion. However, the widespread clinical application of this technique has faced challenges such as inaccurate clinical decision-making (indication and contraindication selection), non-standardized operative practices, and insufficient awareness of complication prevention, resulting in considerable variability in clinical outcomes and even severe complications. To address this, Prof. Luo Fei from First Affiliated Hospital of Army Medical University initiated the project and the Chinese Association Orthopaedic Surgeons organized relevant experts to develop the Evidence-based clinical practice guideline for bone cement-augmented pedicle screw technique ( version 2025), based on current evidence. The guidelines put forward 8 recommendations regarding the clinical value, scope of application, and operational standards of the technique, aiming to provide evidence-based medical support and technical standardization for clinical decision-making.

Objective To explore the impact of gender factors in participant selection during bioequivalence studies,and to provide insights for improving the screening success rate in subsequent trials.Methods A retrospective study was con-ducted to summarize the screening information of healthy subjects in the bioequivalence study conducted in the Phase Ⅰ Clinical Trial Laboratory of the Affiliated Hospital of Xiangnan University from July 2021 to July 2023.The number of failed screening ca-ses in different stages of screening for each project was counted,and the influence of gender factors on subject screening was ana-lyzed.Results A total of 32 bioequivalence studies involving 2 794 subjects,including 1 816 males and 978 females,were in-cluded in the study.The proportion of males was higher in vital signs and BMI abnormalities,and the proportion of females was higher in ECG abnormalities and active withdrawal,and the pass rate was lower in males than in females(40.0％ vs.45.8％),and the existence of the two was statistically significant(P＜0.05).The results of PC A showed that the distribution of data in males was more dispersed,and the distribution of data in females was centralized,and the two could be clearly differentiated.Binary lo-gistic regression analysis showed significant differences between males and females in laboratory test screening failures and BMI(P＜0.05).Further analysis showed that the screening failure rates of blood biochemistry,urine routine,coagulation function and blood transfusion were higher in males than in females,but the screening failure rates of blood routine were lower than those of fe-males.Conclusions Gender is an important influencing factor in the screening process of bioequivalence studies.Including subjects with appropriate gender ratios can help improve enrollment speed and reduce clinical trial costs.

Objective To explore the impact of gender factors in participant selection during bioequivalence studies,and to provide insights for improving the screening success rate in subsequent trials.Methods A retrospective study was con-ducted to summarize the screening information of healthy subjects in the bioequivalence study conducted in the Phase Ⅰ Clinical Trial Laboratory of the Affiliated Hospital of Xiangnan University from July 2021 to July 2023.The number of failed screening ca-ses in different stages of screening for each project was counted,and the influence of gender factors on subject screening was ana-lyzed.Results A total of 32 bioequivalence studies involving 2 794 subjects,including 1 816 males and 978 females,were in-cluded in the study.The proportion of males was higher in vital signs and BMI abnormalities,and the proportion of females was higher in ECG abnormalities and active withdrawal,and the pass rate was lower in males than in females(40.0％ vs.45.8％),and the existence of the two was statistically significant(P＜0.05).The results of PC A showed that the distribution of data in males was more dispersed,and the distribution of data in females was centralized,and the two could be clearly differentiated.Binary lo-gistic regression analysis showed significant differences between males and females in laboratory test screening failures and BMI(P＜0.05).Further analysis showed that the screening failure rates of blood biochemistry,urine routine,coagulation function and blood transfusion were higher in males than in females,but the screening failure rates of blood routine were lower than those of fe-males.Conclusions Gender is an important influencing factor in the screening process of bioequivalence studies.Including subjects with appropriate gender ratios can help improve enrollment speed and reduce clinical trial costs.

For middle-aged and elderly patients with conditions such as spinal fractures and degenerative spinal diseases, spinal internal fixation is a core surgical procedure for reconstructing spinal stability, heavily relying on the biomechanical stability provided by pedicle screw systems. Whereas, these patients are often complicated by osteoporosis that can significantly compromise the stability of the bone-pedicle screw interface, leading to a marked increase in pedicle screw loosening and surgical failure rates. The bone cement-augmented pedicle screw technique, which involves injecting bone cement into the vertebral body or screw trajectory to optimize the mechanical properties of the bone-pedicle screw composite, has been proven to significantly enhance fixation strength and effectively prevent screw-related failures, thereby reducing the incidence of internal fixation failure in high-risk populations undergoing spinal fusion. However, the widespread clinical application of this technique has faced challenges such as inaccurate clinical decision-making (indication and contraindication selection), non-standardized operative practices, and insufficient awareness of complication prevention, resulting in considerable variability in clinical outcomes and even severe complications. To address this, Prof. Luo Fei from First Affiliated Hospital of Army Medical University initiated the project and the Chinese Association Orthopaedic Surgeons organized relevant experts to develop the Evidence-based clinical practice guideline for bone cement-augmented pedicle screw technique ( version 2025), based on current evidence. The guidelines put forward 8 recommendations regarding the clinical value, scope of application, and operational standards of the technique, aiming to provide evidence-based medical support and technical standardization for clinical decision-making.

Objective:To investigate the mediating role of frailty in the relationship between sedentary behavior and quality of life in patients with stable chronic obstructive pulmonary disease (COPD), so as to provide empirical evidence for improving the quality of life in COPD patients.Methods:This was a cross-sectional survey. Two hundred and twenty-eight patients with stable COPD attending outpatient clinic in Chongming Branch of Shanghai Tenth People′s Hospital from January 2022 to February 2023 were selected by convenience sampling method. The General Information Questionnaire, the International Physical Activity Questionnaire, the Tilburg Frailty Indicator, and the COPD Assessment Test Questionnaire were investigated. Structural equation modeling was used to analyze the mediating role of frailty between sedentary behavior and quality of life, and Bootstrap method was used to analyze the mediating effect values.Results:Finally, 219 valid questionnaires were collected. The effective recovery rate was 96.05%(219/228). There were 168 males and 51 females, aged 69(62, 74) years old. The sedentary time of stable COPD patients was 6(5, 8) h/d, the frailty score was 5(3, 7) points, and the quality of life score was (13.56 ± 2.56) points. Pearson correlation analysis showed that the sedentary time, frailty in stable COPD were positively correlated with quality of life( r=0.420, 0.582, both P<0.01), and the sedentary time was also positively correlated with frailty ( r=0.698, P<0.01). Bootstrap method test results showed that the direct effect of sedentary time was 0.228 (95% CI 0.082-0.374), the indirect effect mediated by frailty was 0.169 (95% CI 0.080-0.215), and the total effect was 0.397, and the 95% CI of both the direct effect and the mediated effect did not contain 0. This model was partially mediated model with a 42.57% mediated effect. Conclusions:The quality of life of patients with stable COPD is at an intermediate level, and sedentary behavior can not only directly affect quality of life, but also indirectly affect quality of life by causing or aggravating debilitation. In clinical work, patients should be encouraged to avoid causing or aggravating debilitation due to prolonged sedentary behavior by standing, changing position frequently or performing light physical activities to promote the improvement of quality of life in the stable phase.

Methods: The median sagittal diameter and transverse diameter of the spinal canal from C2 to C7 were measured on CT images. The ratio of the median sagittal diameter to the transverse diameter was calculated. Accordingly, the spinal canal shape of each segment was classified into four, and the specific criteria of lunar phase classification were determined through linear discriminant analysis based on the ratio of the median sagittal diameter to the transverse diameter. The inter-rater reliability of the classification was explored using Kappa coefficients. Finally, the morphology of the different segments of the cervical spinal canal in healthy volunteers was revised and compared. Results: According to the ratio of the median sagittal diameter and the transverse diameter of the cervical spinal canal, the lunar phase classification of the cervical bony spinal canal was determined as follows: full-moon >0.65, 0.55< convex-moon ≤0.65, 0.46≤ quarter-moon ≤0.55, and residual-moon <0.46. The Kappa values of C2–C7 were 0.851, 0.958, 0.823, 0.927, 0.793, and 0.946, and the Kappa value of all C2–C7 segments was 0.854 that mainly presented two forms of full-moon (76.5%) and convex-moon (23.0%). A quarter-moon spinal canal was mainly distributed in C3, C4, C5, and C6; a residual-moon spinal canal was mainly distributed in C4 and C5; and the morphological distribution of C4 and C5 were similar (p>0.05). The frequency of the spinal canal of the residual-moon type was the highest, and the full-moon (6.5%) and residual-moon (7.5%) types of C7 were rare. Conclusions The morphological classification of the cervical spinal canal was established to present anatomical variations. The classification showed good inter-rater reliability.

Objective:To investigate the influence of interbody cage height during oblique lumbar interbody fusion (OLIF) on lumbar biomechanics with different degrees of degeneration and to provide a reference for cage choice.Methods:The finite element model of normal lower lumbar spine (L 3-S 1) was built and validated, then constructed three different degenerative segments in L 3, 4, and the cages with different height (8, 10,12, 14 mm) were implanted into L 4, 5 disc. All the twelve models were loaded with pure moment of 7.5 N·m to produce flexion, extension, lateral bending and axial rotation motions on lumbar spine, and the effects of cage height on range of motion (ROM), intervertebral pressure in adjacent segments and stress in facet joints were investigated. Results:The ROM of adjacent segments and the maximum stress of intervertebral discs increased with the increase of cage height, but this trend was not obvious in moderate and severe degeneration groups. After implantation of 4 different height cages (8, 10, 12, 14 mm), the ROM of L 3, 4 segment reached the maximum during extension. The ROM of mild degeneration group was 2.68 °, 2.71 °, 2.94 °, 2.98 °, moderate degeneration group was 2.33°, 2.37°, 2.41°, 2.49°, and severe degeneration group was 1.94 °, 1.99 °, 2.14 °, 2.21 °. The stress of L 3, 4 intervertebral disc reached the maximum during right bending. The maximum stress of L 3, 4 intervertebral disc was 23.95 MPa, 24.60 MPa, 24.90 MPa and 25.34 MPa in mild group, 25.57 MPa, 25.60 MPa, 25.82 MPa and 25.89 MPa in moderate group, and 25.95 MPa, 25.99 MPa, 26.48 MPa and 27.13 MPa in severe group. The maximum stress of L 3, 4 facet joint was 15.87 MPa, 15.78 MPa, 16.29 MPa and 16.43 MPa in mild group, 15.97 MPa, 16.31 MPa, 16.53 MPa and 16.79 MPa in moderate group, and 16.17 MPa, 16.49 MPa, 16.95 MPa and 17.35 MPa in severe group. Conclusion:For patients with mild lumbar degeneration requiring OLIF surgery, the intervertebral height of the surgical segment should not be overstretched. But for patients with moderate to severe lumbar degenerative disease who need to undergo OLIF surgery, it is recommended that the cage height be 0-2 mm higher than the original intervertebral space height.

Fusion surgery has been an effective modality for the treatment of spinal disorders for more than 100 years. With the increasing understanding of the disease and the increasing maturity of surgical techniques, lumbar fusion has become more widely performed and its efficacy has been conclusively proven. However, fusion surgery inevitably disrupts the original physiologic motion of the spine and limits segmental motion, resulting in a significant increase in disc and joint protrusion stress in adjacent segments. When a newly identified degenerative change on imaging is present in an adjacent segment or an existing degeneration is more aggravated, this is known as adjacent segment degeneration. When clinical symptoms such as pain and numbness in the lower extremities are present that are consistent with degeneration, this is known as adjacent segment disease. Real world studies (RWS) have become a major focus in medical research in recent years. Since it is closer to clinical practice and more practical for decision-making compared with randomized controlled trail (RCT), it is gaining importance in clinical practice. By searching major national and international databases, this article provides a review of risk factors as well as advances in the treatment of lumbar adjacent segment disease in RWS. According to the retrieved literature, there are many factors that contribute to the development and progression of adjacent segment degeneration and disease, which are mainly divided into patient-related factors and surgery-related factors. In general, patient age, weight, spinal-pelvic sagittal parameters, and internal diseases influence the progression of adjacent segment degeneration. Surgery-related risk factors include the number of segments operated on, the surgical approach, interference with adjacent segments, and whether the spinal-pelvicsagittal imbalance is corrected. To prevent the development of adjacent segment disease, patients can slow the progression of adjacent segment degeneration by reducing their own weight and controlling their internal diseases. The physician can also avoid the influence of surgery-related factors through adequate surgical planning and careful intraoperative management. At the same time, surgeries may be performed in patients who have developed adjacent segmental disease and for whom conservative treatment has failed. The current revision surgical approaches include endoscopic simple decompression and posterior decompression with extended internal fixation.Short-term RWS revealed that the efficacy of endoscopic treatment of adjacent spondylosis might be equivalent to re-fusion internal fixation surgery. Studies with large samples and long-term follow-up are still needed to guide the treatment of adjacent segment disease in the future, in order to improve clinical decision-making.

Objective:To investigate the value of whole-lesion histogram parameters of apparent diffusion coefficient (ADC) in evaluating and predicting the pathological complete response(PCR) to neoadjuvant chemotherapy (NAC) in different subtypes of breast cancer.Methods:This retrospective study included 117 patients with breast cancer who underwent MRI examination before NAC prior to surgery from January 2016 to December 2017 in the First Affiliated Hospital of Nanjing University. All cases were divided into Luminal B, HER2 positive ( n=21) and triple negative ( n=26) groups. The surgical pathology after chemotherapy was evaluated by Miller-Payne (M-P) system and the patients were divided into PCR group and non-PCR (nPCR) group. Firevoxel software was used to generate the whole-lesion ADC histogram. The parameters included mean (ADC mean), skewness, kurtosis, the minimum (ADC min), the maximum (ADC max), 10th percentile(ADC 10%), 50th percentile (ADC 50%) and 90th percentile (ADC 90%). The two independent samples t test or Mann-Whitney U test was used to compare the differences between PCR and nPCR groups in each subtype. The diagnostic performance of statistically different ADC parameters for predicting PCR was evaluated by receiver operating characteristic (ROC) curve. Results:Kurtosis was significantly higher in PCR group than that in nPCR group in HER2 positive subtype ( P=0.039). It achieved an area under the curve (AUC) of 0.813 with sensitivity of 100% and specificity of 68.7% at the optimal cutoff value (1.861) for differentiating PCR from nPCR cases. In triple negative subtype, ADC mean and ADC 50% were smaller in PCR group than those in nPCR group ( P=0.028,0.013). They achieved AUCs of 0.800, 0.842, respectively. When ADC mean of 1.030×10 -3 mm 2/s and ADC 50% of 0.976×10 -3 mm 2/s were used as cutoff value to differentiate PCR from nPCR, the sensitivities were 75.0%, 80.0% and the specificities were 83.3%, 83.3%, respectively. Conclusion:Kurtosis can predict post-NAC PCR in patients with HER2 positive breast cancer, while ADC 50% has a high value in predicting post NAC PCR of triple negative breast cancer patients.

Objective To explore the mediating role of self-confidence in the parental rearing style and facing-audience com munication apprehension(FACA).Methods The Chinese College Students' Facing-audience Communication Apprehension Scale (revised version of 2011),the Short-form Egna Minnen av Barndoms Uppfostran for Chinese(s-EMBU-C) and the Overall Self-confidence Questionnaire Version of College Students were adopted to survey on 1 072 college freshmen from Guizhou Province.Results FACA in the freshmen of non-one-child was significantly higher than that in the freshmen of one-child,FACA in the freshmen of good performance was significantly lower than that in the freshmen of middle and poor performance;FACA of college freshmen,parental rearing style and self-confidence were significantly correlated with each other;self-confidence played a complete mediated role between the parental care and FACA,and a partial mediated role between the parental control and FACA.Conclusion Self-confidence has significant mediate effect between the parental rearing style and FACA of college freshmen.